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We are no longer recruiting
volunteers for this particular study. Please call our office at (860) 443-4567, for information about similar upcoming clinical research studies
Clinical Trial for Men and
Women Previously Diagnosed
with Irritable Bowel Syndrome
The
following is an overview of this clinical research trial and is intended to
provide prospective patients with information that may help them decide whether
to consider participating in the trial. Please note that there are additional
details regarding participating that are not listed on this page. These will be
discussed in person by a member of Coastal Connecticut Research, LLC, and all
relevant information will be provided in the Informed Consent Form that must be
read by the prospective participant.
Summary
Irritable Bowel Syndrome (IBS) is a chronic disorder with symptoms that include
abdominal pain, discomfort, and altered bowel function. Those suffering from
IBS are generally grouped by their bowel movement patterns. Some people
experience mostly diarrhea, others mostly constipation, some tend to go back and
forth between diarrhea and constipation.
Study
Medication
This investigational study is designed to compare doses of an investigational
drug to a placebo (an identical appearing pill containing no active ingredient)
to see if it relieves abdominal discomfort and/or pain in patients previously
diagnosed with Irritable Bowel Syndrome.
This
study is “double-blind” which means that neither you nor the study doctor or his
research staff will know whether you are receiving the study medication or the
placebo.
Basic
Eligibility Requirements
Ø
Male or Female,
between the ages of 18-70 years
Ø
Must be
ambulatory (not needing a wheelchair)
Ø
Previously
diagnosed with IBS
Ø
Presence of
abdominal pain or discomfort for at least 12 weeks (not necessarily consecutive)
out of the preceding year, experiencing
o
Relief with
defecation, or
o
Onset with
change in stool frequency, or
o
Onset with
change in stool consistency
Ø
Participants
must have normal results from a colonoscopy or barium enema and flexible
sigmoidoscopy performed within 5 years.
Ø
Ability to
complete daily diary by phone or computer.
Additional inclusion and exclusion criteria apply and will be reviewed with you.
Testing provided at no charge:
The study will
last approximately 14 weeks and will include 5 office. Qualified participants
will receive study-related exams and investigational study medication. Study
related physical exams, lab work, EKGs and pregnancy tests will be performed
free of charge.
Participants will be asked to access an interactive voice response system (IVRS)
by telephone or secure computer website every day to report their IBS symptoms.
Duration
of study:
Ø
14 weeks
Ø
5 study visits;
study medication is dispensed after eligibility is confirmed at visit 2.
Compensation
Eligible participants who are enrolled in the trial will receive $35
compensation for time and travel for each completed visit.
Principal Investigator Sub-Investigator
Robert
M. Spitz, M.D. Alan J. Greenwald, M.D.
Please note:
The preceding is an overview of this clinical trial and is intended to provide
prospective patients with information that may help them decide whether to
consider participating in the trial. There are additional details regarding
study eligibility criteria, and details important to making a final decision
regarding participating that are not listed on this page. These will be
discussed with interested participants over the phone and in person by a member
of Coastal Connecticut Research. All relevant information will be provided in
the Informed Consent Form that must be reviewed by the prospective participant.
At Coastal Connecticut Research, LLC we are excited to introduce this
investigational medication to you, and hope that you will consider joining us in
this trial.
If you
would like more information, or to see if you qualify for this study, please
contact study coordinators:
Carolyn Eustace, RA
Karen Cuddy, RN
(860) 443-4567
or contact us by e-mail at
CCRvolunteer@gmail.com
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